- Fresenius Medical Center (Waltham, MA)
- …a medium-sized company + Supporting the department in cross-site activities to monitor product quality and regulatory compliance **EOE, disability/veterans** ... + Experience in project management respectively change control process + Experience in regulatory affairs or in a quality environment, ideally in a… more
- Dana-Farber Cancer Institute (Brookline, MA)
- The Regulatory Compliance Manager at Dana-Farber is responsible for coordinating and leading regulatory compliance activities across all sites. This ... program and providing expertise on regulatory needs throughout the organization. The Regulatory Compliance Manager works under the Director of Clinical … more
- Abbott (Westford, MA)
- …This position is responsible for developing, establishing and maintaining quality systems programs, policies, processes, procedures, training materials, and controls ... enhancing the performance and quality of products and the divisional capability to demonstrate...+ Provide expert level guidance and direction of the Quality Systems Body-of-Knowledge + Aggressively identify opportunities to apply,… more
- Philips (Cambridge, MA)
- …responsible for enhancing tracking and controlling systems to optimize regulatory compliance monitoring and reporting efficiency, implementing robust ... The Regulatory Affairs Program Manager will play...Leads strategic initiatives towards enhanced performance to further improve regulatory compliance efforts and reviews the creation… more
- Prime Therapeutics (Boston, MA)
- …decision we make. **Job Posting Title** Senior Functional Business Consultant/ Regulatory Compliance exp required- REMOTE **Job Description** The Functional ... Government Programs, Corporate Compliance ) + Advise internal clients regarding compliance with State and Federal Medicaid regulatory and contractual… more
- Takeda Pharmaceuticals (Boston, MA)
- …improve efficiency, productivity and quality and consistency across products and compliance with regulatory labeling guidance. + Project manages new or ... with immunologic, hematologic, and other complex diseases. The Global Regulatory Device Labeling Strategy Lead (Senior Manager )...updated labeling to ensure compliance with internal procedural or Health Authority submission timelines.… more
- AbbVie (Cambridge, MA)
- …(RSTP) for assigned on market products or those products in development. The Manager assists Regulatory Staff by identifying and gathering data needed to ... for a product(s) within Neuroscience and supports the Manager (Senior Manager , Associate Director, Director (Global Regulatory Lead (GRL)), in the… more
- Eversource Energy (Westwood, MA)
- … proceedings\. + Ensures appropriate individuals within Eversource are aware of regulatory changes and compliance obligations\. + Ensures filings are ... for working across Eversource to identify and respond to regulatory obligations in as established by law and the...to manage multiple dockets simultaneously, as well as multiple compliance orders, using problem solving skills and critical path… more
- Otsuka America Pharmaceutical Inc. (Boston, MA)
- …assigned project teams, to ensure Otsuka's products are developed/maintained in compliance with global regulatory requirements and guidances. Primary ... all CMC and GMP related documents for submission to regulatory authorities to assure compliance with ...portals is a plus. + Interact with manufacturing and quality groups, partner organizations, regarding CMC issues. + Independently… more
- Grifols Shared Services North America, Inc (Medford, MA)
- …more than 110 countries and regions. **Summary:** Develops and implements worldwide regulatory programs for marketed products and/or those for development, and has ... interactions with regulatory authorities to expedite approvals. Participate in the development...May have responsibility for maintaining a compliant medical device quality system for R&D and informing project teams of… more
- Curia (Burlington, MA)
- …with Global/ BU Quality departments and other key stakeholders * Support Quality Systems by driving regulatory compliance and continuous improvement ... Manager , Quality Systems and Compliance... Manager , Quality Systems and Compliance - Burlington,...meetings * Participate in FMEA's, gap assessments and drive regulatory compliance * Provide audit support (… more
- Point32Health (Canton, MA)
- … Compliance Program Manager II is responsible for managing compliance and regulatory projects and initiatives with significant cross-functional interface ... and complex regulatory scope. Responsibility may include development of ...analytical skills. By using knowledge of the company, the Compliance Program Manager II should be able… more
- Dana-Farber Cancer Institute (Boston, MA)
- …submits regulatory documents, and maintains records on assigned studies to ensure regulatory compliance with DFCI and DF/HCC policies as well as federal ... work with amazing partners, including other Harvard Medical School-affiliated hospitals. ** Regulatory Compliance ** + Prepares and submits all protocol… more
- Dana-Farber Cancer Institute (Brookline, MA)
- …submits regulatory documents, and maintains records on assigned studies to ensure regulatory compliance with DFCI and DF/HCC policies as well as federal ... work with amazing partners, including other Harvard Medical School-affiliated hospitals. + ** Regulatory Compliance ** + Prepares and submits RAS Center protocol… more
- Prime Therapeutics (Boston, MA)
- …Posting Title** Manager , Compliance - Remote **Job Description** The Compliance Manager works closely with designated business areas, Legal, and other ... changing laws and regulations, accreditation standards, and client contractual compliance obligations, interpret the impact, and manage solutions for designated… more
- Fresenius Medical Center (Waltham, MA)
- …wide range of issues in creative ways. + Responsible for the preparation, compilation, quality check and delivery of regulatory submissions in both paper and/or ... AND SCOPE:** Assists in the support of the daily operational activities within Regulatory Affairs for the preparation of regulatory submissions required to… more
- Lumen (Boston, MA)
- …the world and shape the future. **The Role** Lumen is looking for an experienced manager to bolster and drive our compliance programs. Reporting to the Senior ... compliance , consistency, and effectiveness. The Information Security Governance Manager will lead a team responsible for developing, maintaining, and enhancing… more
- MIT Lincoln Laboratory (Lexington, MA)
- …for additional information. Position Description MIT Lincoln Laboratory is seeking a Senior Compliance Manager to join our team to ensure compliance ... contract, such as grants, SBIRs, and CRADAs. As directed, the Senior Compliance Manager will review all Laboratory purchase orders, subcontracts, electronic… more
- Nanobiosym, Inc. (Cambridge, MA)
- …and requirements are below. The CLIA (Clinical Laboratory Improvement Amendments) Quality Manager will provide quality and compliance oversight to the ... top notch candidates to help the company scale up its operations. Nanobiosym is looking for a Quality Manager for its High-Complexity Testing CLIA LAB. The role… more
- Takeda Pharmaceuticals (Boston, MA)
- …is true to the best of my knowledge. **Job Description** **About the role:** The Quality Compliance and Systems, Senior Manager is responsible for ensuring ... (ECs) originated from audits, and/or quality events/deviations. + Support R&D Quality Compliance and Systems and stakeholders for internal audits related to… more